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Overweight and ObesityNCT03314415

Pilot Study on Weight Loss With Robotic Assistance

A study testing Aldebaraan Nao H25 in people with Overweight and Obesity and Weight Loss, run by Tufts University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to determine whether robotic assistance can help facilitate adherence, engagement, and weight loss in participants enrolled in a behavioral weight loss program. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity, Weight Loss
What is being tested?
Aldebaraan Nao H25
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
11 Oct 2018to 30 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women who are overweight or obese (body mass index of 25-40 kg/m2)
  • Want to lose weight and enroll in the study, and are willing to sign the informed consent form
  • Able to meet the study requirements for food habits and able to attend online videoconference sessions
  • Willing and able to attend in-person robotic assistance sessions, and are not planning to be out of town for more than five days during the study

Who cannot join

  • Self-reported serious food allergies/intolerances, dietary patterns, or active health conditions (e.g., irritable bowel syndrome, Crohn's disease, celiac disease) that would prevent consumption of recommended foods.
  • Concurrent participation in another weight loss program or >2 hours/day of exercise on average.
  • Actively dieting or self-reported weight loss of >10 lb in the past 3 months
  • Vulnerable populations, including women who are pregnant and adults who are unable to consent
  • Women who are lactating or planning to become pregnant within two months of the start date, per self-report
  • Diagnosis of a serious mental health condition
Show all 11Show fewer
  • Non-English speaking individuals
  • Medical complications or chronic illness that would prevent full participation (e.g., active cancer)
  • Surgical procedures that influence hunger or satiety (e.g., gastric bypass, bowel rerouting, stomach sleeve)
  • Primary training as a Clinical Nutritionist or practicing Registered Dietitian
  • Diagnosed eating disorder

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tufts University

    Boston, Massachusetts, 02111

Other trials in United States

About this study

The purpose of this study is to determine whether robotic assistance can help facilitate adherence, engagement, and weight loss in participants enrolled in a behavioral weight loss program. All participants will be enrolled in the same Web-based weight loss program and take part in "robotic assistance sessions" either early or late in the five-week study. These robotic assistance sessions involve speaking one on one with a robot about diet-related progress.

Read the detailed description

At the start of the five-week study, all participants will be enrolled in a Web-based behavioral weight loss program. The weight loss program places particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. The program will consist of six videoconference sessions delivered by a qualified coach. Menus and other program materials will be available to the participants throughout the study period.

Participants also will be assigned to attend one-on-one "robotic assistance sessions" either early or late in the five-week study. During each robotic assistance session, the participant will speak with the robot about his/her progress with the weight loss program. The robot is programmed to respond to specific issues raised by the participant, but a human operator with thorough knowledge of the weight loss program will be available in case the conversation goes "off script." This human operator can initiate robot behaviors and prompt verbal responses through a text-to-speech interface.

Data from this study will be used to refine the robot for future use and determine whether robotic help can improve a participant's experience in a previously tested weight loss program.

Being tested
Aldebaraan Nao H25
Keywords
overweight, obesity, weight loss, robot
Medical subject headings
Overweight, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aldebaraan Nao H25Device

    The Aldebaraan Nao H25 is a humanoid robot with the capability to interact with people through small movements, gestures, and speech. It does not physically touch the participant at any time.

Study groups in NCT03314415
Study groupRoleWhat they receive
Early robotic interventionExperimentalParticipants randomized to the early robotic intervention will attend robotic assistance sessions for a two-week period earlier in the study (during the first half of the study, approximately). Each participant will attend ten 15-minute robotic assistance sessions to interact with a robot (Aldebaraan Nao H25).
Receives: Device: Aldebaraan Nao H25
Late robotic interventionExperimentalParticipants randomized to the late robotic intervention will attend robotic assistance sessions for a two-week period later in the study (during the latter half of the study, approximately). Each participant will attend ten 15-minute robotic assistance sessions to interact with a robot (Aldebaraan Nao H25).
Receives: Device: Aldebaraan Nao H25

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight change

    Primary outcome is weight change during the with-robot and without-robot periods adjusted for week of weight loss.

    Measured: 5 weeks

Secondary outcomes (7)

  1. Change in self-reported eating behavior

    Participants will complete the Three-Factor Eating Questionnaire, consisting of 18 items, which will be used to assess eating behavior on a 4-point response scale (4=definitely true;3=mostly true;2=mostly false;1=definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summed into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Total scores will be reported and higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating. Questionnaires are self-administered.

    Measured: Baseline, once during with-robot phase, Week 5

  2. Change in self-reported food cravings

    Participants will complete the Food Cravings Questionnaire - Trait, which will be used to assess food cravings on a 6-point response scale (1=Never or NA;2=Rarely; 3=Sometimes;4=Often;5=Usually;6=Always). Responses to each of the 39 items are given a score between 1 and 6 and item scores are summed into scale scores with higher scores being indicative of greater eating pathology, body mass index (BMI), low dieting success and increases in state food craving during cognitive tasks. Total scores will be reported. Questionnaires are self-administered.

    Measured: Baseline, once during with-robot phase, Week 5

  3. Self-reported quality of life

    Participants will complete the RAND 36-Item Short Form Survey, which will be used to assess eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered.

    Measured: Baseline, once during with-robot phase, Week 5

  4. Participant engagement with the robot

    Visual analog scales, measured by the robot, will be analyzed to evaluate participant engagement during each of the ten 15-minute robotic assistance sessions that will occur over the course of two weeks.

    Measured: 2 weeks

  5. Robot adherence

    Robot adherence will be measured based upon attendance to the robotic assistance sessions. Each participant will be scheduled to attend ten robotic assistance sessions.

    Measured: 2 weeks

  6. Dietary intake

    Dietary intake will be determined by two 24-hour diet recalls. One 24-hour recall will occur during the with-robot phase and the other will occur during the without-robot phase.

    Measured: Two 24-hour periods

  7. Program adherence

    Adherence to the iDiet will be measured by the number videoconference sessions attended by the participant. Each participant will be scheduled to participate in six videoconference sessions (one/week), each one hour long.

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2017
  2. Study start11 Oct 2018 (estimated)
  3. Primary completion30 Nov 2018 (estimated)
  4. Study completion30 Nov 2018 (estimated)

Why it stopped: Study will not be implemented and did not enroll participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Robotic-assisted weight loss
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03314415
Sponsor's protocol ID
12561
Status last verified
Nov 2018
First submitted
17 Jul 2017
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salinardi TC, Batra P, Roberts SB, Urban LE, Robinson LM, Pittas AG, Lichtenstein AH, Deckersbach T, Saltzman E, Das SK. Lifestyle intervention reduces body weight and improves cardiometabolic risk factors in worksites. Am J Clin Nutr. 2013 Apr;97(4):667-76. doi: 10.3945/ajcn.112.046995. Epub 2013 Feb 20.

    PubMed 23426035

  • Briggs P, Scheutz M, Tickle-Degnen L, editors. Are Robots Ready for Administering Health Status Surveys': First Results from an HRI Study with Subjects with Parkinson's Disease. Proceedings of the Tenth Annual ACM/IEEE International Conference on Human-Robot Interaction; 2015: ACM.

Questions about this trial

What is this clinical trial studying?

A study testing Aldebaraan Nao H25 in people with Overweight and Obesity and Weight Loss, run by Tufts University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight change (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314415, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.

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